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Originator: MHRA Drug Alerts

 
From: Himal Makwana

Issue date: 27-Jan-2020 09:59:40

Action by recipients:
  • NHS Regional Offices
  • NHS Foundation Trusts (England) - Medical Director
  • NHS Trusts (England) - Medical Director
  • Territorial CMOs in Northern Ireland, Scotland & Wales
  • Regional Directors of Public Health

Information to recipients:
  • MHRA (Medicines) Drug Alerts (Various Recipients)
  • Other contacts
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • NHS Foundation Trusts (England) - Chief Executive
  • MHRA (Medicines) Drug Alerts - Non-NHS Recipients
  • Director of Public Health
  • NHS Trusts (England) - Chief Executive
  • GP - Locum
  • Dispensing GP Practices
  • GP Practices

Action category: Class 2: Action within 48 hours

Title: CLASS 2 DRUG ALERT, ACTION WITHIN 48 HOURS, LEO LABORATORIES LTD (T/A LEO PHARMA), PICATO 150MCG/G GEL AND PICATO 500MCG/G GEL (INGENOL MEBUTATE)

Broadcast content: LEO Laboratories Ltd (T/A LEO Pharma) is recalling all unexpired stock of Picato Gel (ingenol mebutate) from pharmacies and wholesalers as a precautionary measure due to concerns on the possible risk of skin malignancy. The recall is a precautionary measure following the suspension of the marketing authorisation for Picato, while investigations are ongoing.

Full details of the drug alert are included in the attached PDF file. Please forward to listed recipients. This information is also published on the MHRA website https://www.gov.uk/drug-device-alerts.


Additional information: NHS England Regional Offices: Please cascade this alert to community pharmacies.
GP Practices: Please share this alert within your practice to assist the management of patients who use these medicines.


Alert reference: EL (20)A/02

Attachments:
Cascade to:
  • #GP#
  • #COMMUNITYPHARMACISTS#
  • #DISPENSING GP#
  • #HospitalPharmacy#


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency